The present invention relates to the administration of medicament to a patient. More particularly, it relates to apparatus and methods for the administration of reconstituted medicaments; that is, medicaments that are packaged in concentrated or dehydrated form, and that must be diluted or reconstituted by the addition of a liquid constituent before administration to a patient.
Medicaments for administration to a patient by injection, such as many types of chemotherapy preparations, are sometimes packaged and shipped in a concentrated or dehydrated form, such as, for example, a dehydrated powder or a concentrated liquid. Before these dehydrated or concentrated medicaments can be administered to patients, they must be reconstituted. The reconstitution process involves adding a liquid rehydration or dilution component or constituent to the concentrated or dehydrated medicament. The reconstituted medicament is then administered to a patient. The administration may be direct, as through an injection by syringe, or indirect, as through injecting the reconstituted medicament into an intravenous (IV) bag, from which the medicament is delivered intravenously to the patient.
An important consideration in handling many such medicaments, particularly highly toxic chemotherapy preparations, is to minimize the release of the medicament to the ambient environment. Indeed, compliance with regulatory standards may necessitate near-zero release of medicament to the ambient environment. Consequently, there has been a long-sought need for a “closed” system for reconstituting and administration such medicaments, in which the medicament is reconstituted and administered under conditions of effective isolation from the environment.